🇪🇸 ValiPro: AEMPS, EU GMP & eCTD Process Validation Services for Spain

The regulatory authority for pharmaceuticals in Spain is the Spanish Agency for Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS), which is under the Ministry of Health.

As an active and influential member of the European Union (EU), Spain's regulatory framework is fully harmonized with the standards of the European Medicines Agency (EMA). This means that requirements for process validation are among the strictest globally and fully adhere to EU regulations.

🇪🇸 ValiPro: AEMPS, EU GMP & eCTD Process Validation Services for Spain

Achieve Compliance and Secure Product Registration in Spain by Meeting the Rigorous EU GMP and AEMPS-Enforced Quality Standards.

ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting Spain and the wider EU/EEA market. Our documentation is built for full compliance with the standards enforced by the AEMPS.

Key compliance pillars include:

• Mandatory adherence to EU Good Manufacturing Practice (EU GMP) Guidelines (EudraLex Volume 4).

• Mandatory submission of the registration dossier in the electronic Common Technical Document (eCTD) format.

• Strict alignment with EMA's scientific guidelines on quality and validation, particularly those referencing the ICH Q8, Q9, and Q10 lifecycle approach.

🌟 Why AEMPS/EU Validation is Critical for Spain

Market Authorization (MA) in Spain is achieved through EU-level procedures (Centralized, DCP, or MRP), meaning your validation documents must satisfy the highest scientific and quality standards in Europe.

• EU GMP Mandate & Inspection: The AEMPS is a key participant in the EU/EEA GMP inspection network. Manufacturers must hold a valid GMP certificate. The AEMPS's inspections of foreign facilities (when required) rigorously assess compliance with EudraLex Volume 4, Annex 15 (Qualification and Validation), which outlines the requirements for Process Validation across the entire product lifecycle.

• eCTD Submission: Registration is handled via the Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), or the National Procedure. All require the dossier to be submitted in the electronic eCTD format. Process Validation reports and the Quality Overall Summary (QOS) are mandatory within Module 3 (Quality), section 3.2.P.3.5.

• EMA Scientific Guidelines: AEMPS assessors follow the EMA Guideline on process validation for finished products, which encourages the use of an enhanced approach to process validation, utilizing Quality by Design (QbD) principles (ICH Q8) and Continuous Process Verification (CPV) (ICH Q10).

• Reference Member State (RMS): Due to its technical expertise, Spain is often selected as the Reference Member State (RMS) for DCP or MRP applications. Acting as the RMS demands an impeccable quality dossier, with validation data that is scientifically robust and flawlessly presented.

🎯 Compliance Focus: Who We Support

We work with manufacturers targeting the Spanish market via the European procedures:

• EU Exporters: Targeting human and veterinary drug registration through the Centralized, DCP (with Spain as RMS or Concerned Member State), or MRP routes.

• EU GMP Audit Readiness: Foreign facilities preparing for an EU GMP inspection by the AEMPS or another EU inspectorate.

• CTD Module 3 Quality: Firms needing expert preparation of Module 3 to meet AEMPS's technical standards, supporting all validation approaches (Traditional, Hybrid, or CPV).

🛠️ Our Process Validation Services for Spain and the EU

We provide complete, scientifically sound, and document-intensive support to meet the AEMPS's expectations for EU-aligned quality data.

ServiceAEMPS / EU GMP / EMA FocusPVP & PVR PreparationProtocols and reports aligned with EudraLex Vol. 4, Annex 15 and the EMA's specific validation guidelines, covering the three stages of the validation lifecycle.eCTD Module 3 IntegrationStructuring validation summaries and data precisely for the eCTD Module 3 (section 3.2.P.3.5), ensuring compliance with the ICH Q8/Q9/Q10 principles.Spanish Technical Review SupportAssistance in preparing technical summaries and data for optimal presentation during the AEMPS scientific assessment.Deficiency Response SupportExpert technical support to address and close quality (Module 3) non-conformities and validation-related deficiencies issued by the AEMPS during the registration process.

📜 Regulatory Standards We Follow

Our documentation is engineered to align with the core standards adopted and enforced by the Spanish Agency for Medicines and Medical Devices:

• EudraLex Volume 4 (EU GMP) Annex 15: The mandatory guideline for manufacturing practice and validation.

• EMA Scientific Guidelines: The primary guidelines on Process Validation and Quality.

• ICH Q8, Q9, Q10: The globally harmonized principles of Quality by Design (QbD) and the Process Validation lifecycle.

🤝 Get Started on Your AEMPS/EU Validation

Ensure your process validation documentation is robust and immediately acceptable to the AEMPS, securing your necessary approvals and market access in Spain and the European Union.

To receive a Technical Scope and Commercial Proposal tailored for your Spanish/EU project, simply provide:

• Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size

• Target Procedure: DCP (Spain RMS?) / MRP / National Registration

• Manufacturing Process: Overview of critical steps and control strategy

• Timeline: Submission or inspection date

• Existing Data: Any current validation documents or AEMPS/EU deficiency letters.